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FDA > CDRH > Information on Premarket Approval Applications > PMA Final Decisions Rendered for November 2008

PMA Final Decisions Rendered for November 2008

Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available. Information about the PDF Reader is available.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P080011 11/19/08	BIOFINITY® (comfilcon A) Soft Contact Lens for Extended Wear alternate trade names: Aquaclear™ (comfilcon A) Soft Contact Lens and SiH48 (comfilcon A) Soft Contact Lens	CooperVision, Inc, Pleasanton, CA 94588	Approval for the BIOFINITY® (comfilcon A) soft contact lens. This device is indicated for use as follows: BIOFINITY® (comfilcon A) Sphere and Aspheric soft contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. BIOFINITY® (comfilcon A) Toric soft contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.00 diopters. BIOFINITY® (comfilcon A) Multifocal soft contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters with add powers from +0.50 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. BIOFINITY® (comfilcon A) Contact Lenses may be prescribed for Extended Wear for up to 6 nights and 7 days of continuous wear. It is recommended that the contact lens wearer be first evaluated on a Daily Wear schedule prior to overnight wear. The lenses may be prescribed for either one week disposable wear or for frequent replacement with cleaning, disinfection and scheduled replacement. When prescribed for frequent replacement, the lenses must be cleaned and disinfected using a chemical disinfection system only.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
N12159/S023 11/26/08 180-Day	Surgicel® Absorbable Hemostat	Ethicon Women’s Health & Urology Somerville , NJ 08876	Approval for manufacturing sites located at: 1) Ethicon SARL, Neuchatel, Switzerland; 2) Ethicon SARL, Marin Switzerland (warehouse); and 3) Studer AF/Werk Hard, Daniken, Switzerland (contract sterilizer).
N16895/S090 11/3/08 Real-Time	Bausch & Lomb® SofLens® (polymacon) Contact Lens	Bausch & Lomb, Inc. Rochester , NY 14609	Approval for using a new supplier of polypropylene resin for the contact lens blister packs.
P810002/S065 11/5/08 180-Day	St. Jude Medical Mechanical Heart Valves	St. Jude Medical St. Paul , MN 55117	Approval for a manufacturing site located in St. Paul, Minnesota.
P810002/S068 11/14/08 Real-Time	SJM Regent Mechanical Heart Valve	St. Jude Medical St. Paul , MN 55117	Approval for modifications and rearrangement of the Instructions for Use (IFU).
P820003/S084 11/21/08 180-Day	Various Families of Implantable Pulse Generators (IPGs)	Medtronic, Inc. Mounds View, MN 55112	Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components.
P840001/S098 11/5/08 Real-Time	N’Vision Programming System	Medtronic Neurological Minneapolis , MN 55432	Approval for software updates made to N’Vision Programming System model 8840.
P850051/S068 11/21/08 180-Day	Various Families of Implantable Pulse Generators (IPGs)	Medtronic, Inc. Mounds View, MN 55112	Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components.
P860004/S089 11/5/08 180-Day	Medtronic SynchroMed II	Medtronic Neurological Minneapolis , MN 55432	Approval for the Medtronic Model 8835 Personal Therapy Manager (myPTM) and the Model 37092 Detachable antenna.
P860004/S090 11/10/08 180-Day	Medtronic SynchroMed Pump and Infusion System (SynchroMed EL and SynchroMed II)	Medtronic Neurological Minneapolis , MN 55432	Approval for the software changes made to the SynchroMed EL and SynchroMed II application software located on Model 8870 Application card.
P860019/S208 11/7/08 180-Day	Apex™ Monorail™ and Over-the-Wire PTCA Dilatation Catheters	Boston Scientific Corporation Maple Grove , MN 55311	Approval for the Apex™ Monorail™ and Over-the-Wire Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. The device, as modified, is indicated for: 1) (balloon models 1.5 – 5.0 mm) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; and 2) (balloon models 2.0 – 5.0 mm) for the post-delivery expansion of balloon expandable stents.
P880047/S012 11/26/08 180-Day	Interceed® Absorbable Adhesion Barrier	Ethicon Women’s Health & Urology Somerville , NJ 08876	Approval for manufacturing sites located at: 1) Ethicon SARL, Neuchatel, Switzerland; 2) Ethicon SARL, Marin Switzerland (warehouse); and 3) Studer AF/Werk Hard, Daniken, Switzerland (contract sterilizer).
P890003/S145 11/21/08 180-Day	Various Families of Implantable Pulse Generators (IPGs)	Medtronic, Inc. Mounds View, MN 55112	Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components.
P900056/S086 11/5/08 Real-Time	Rotablator™ Rotational Angioplasty System	Boston Scientific Corporation Maple Grove , MN 55311	Approval for the inclusion of additional electromagnetic compatibility (EMC) information in the Rotablator Console Directions for Use.
P900061/S077 11/21/08 180-Day	Various Families of Implantable Cardioverter Defibrillators (ICDs)	Medtronic, Inc. Mounds View, MN 55112	Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components.
P910023/S183 11/26/08 135-Day	Cadence Family of ICDs	St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086	Approval for a change to eliminate a chemical cleaning process for titanium case halves.
P910023/S190 11/14/08 Real-Time	HV Ceramic RF Module for the Current RF ICDs and Promote RF CRT-Ds	St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086	Approval for the HV Ceramic RF Module for the Current RF ICDs and Promote RF CRT-Ds.
P910023/S191 11/14/08 Real-Time	Cadence ICD System Merlin@home Model EX1100 Transmitter	St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086	Approval for the Merlin@home Model EX1100 Transmitter with inductive telemetry.
P910023/S194 11/26/08 Real-Time	Current ICD	St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086	Approval for minor changes to the Xena controller integrated circuit chip in the Current and Promote ICD/CRT-D devices.
P910073/S075 11/7/08 Real-Time	Endotak Reliance Family Active Fixation Tachy Leads	Boston Scientific CRM St. Paul , MN 55112	Approval for a lumen seal modification on Endotak Reliance, Reliance S, Reliance G, and Reliance SG lead families.
P910077/S090 11/17/08 180-Day	Latitude™ Communicator Software & System Software	Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112	Approval for the Next Generation (G2) RF communicator, Model 6476, which in conjunction with the Latitude System Software, v5.0, Model 6488, will add Latitude support for Cognis Teligen PGs.
P920015/S045 11/14/08 135-Day	Sprint Quattro Secure Lead Model 6935	Medtronic, Inc. Mounds View, MN 55112	Approval for a change in the treatment process for the lead silicone tubing.
P930022/S007 11/21/08 180-Day	Legend Plus IPGs	Medtronic, Inc. Mounds View, MN 55112	Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components.
P950037/S059 11/4/08 180-Day	Actros, Axios, BA03, Cylos, Dromos, Kairos, Philos, Philos II, and Protos Families of Pulse Generators	Biotronik, Inc. Lake Oswego , OR 97035	Approval for the addition of models 500/540 to the Lumax family of ICD/CRT-Ds and ICS 3000 Programmer. These models would contain: • A third programmable cardioversion / defibrillation shock pathway to offer more programming options • Automatic Threshold Measurement (ATM) feature • Electronic module (hardware) updates to support the third programmable shock path • Modifications to the Litronik batteries to increase capacity • New standard value of the programmable pacing pulse width • Updated RAM firmware to support new features
P950037/S064 11/24/08 Real-Time	Cylos DR-T Pulse Generator	Biotronik, Inc. Lake Oswego , OR 97035	Approval for modifications to the header assembly and a correction to the technical manual.
P950037/S065 11/6/08 Real-Time	Philos II Family of Pulse Generators	Biotronik, Inc. Lake Oswego , OR 97035	Approval for modifications to the integrated circuits, header and can of the Philos II Family of Pulse Generators.
P950037/S066 11/21/08 Real-Time	Philos II and Cylos Families of Pulse Generators	Biotronik, Inc. Lake Oswego , OR 97035	Approval for updates to the Home Monitoring Service Center used with the Philos II and Cylos Families of Pulse Generators Lexos and Lumos Families of Implantable Cardioverter Defibrillators. Stratos LV-T Pulse Generator. Cardiac Airbag-T and Belos VR-T Implantable Cardioverter Defibrillators, and the Kronos LV-T and Lumax Families of Implantable Cardioverter Defibrillators.
P960009/S041 11/5/08 Real-Time	N’Vision Programming System	Medtronic Neurological Minneapolis , MN 55432	Approval for software updates made to N’Vision Programming System model 8840.
P960022/S005 11/3/08 Real-Time	Bausch & Lomb® SofLens® 66 and SofLens® Toric (alphafilcon A) Contact Lens	Bausch & Lomb, Inc. Rochester , NY 14609	Approval for using a new supplier of polypropylene resin for the contact lens blister packs.
P960040/S174 11/17/08 180-Day	Teligen Family of ICD’s	Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112	Approval for the Next Generation (G2) RF communicator, Model 6476, which in conjunction with the Latitude System Software, v5.0, Model 6488, will add Latitude support for Cognis Teligen PGs.
P960040/S178 11/14/08 Real-Time	Teligen Family of ICD’s	Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112	Approval for changes to the Vitality HE programmer software Model 2896 Version 2.01, affecting the Vitality HE family of ICDs.
P970003/S102 11/12/08 Special	NeuroCybernetic Prosthesis (NCP®) Programming Wand, Model 201	Cyberonics, Inc. Houston , TX 77058	Approval for labeling changes that include the addition of confirmatory testing information, strengthening of warnings, and formatting revisions.
P970012/S038 11/21/08 180-Day	Various Families of Implantable Pulse Generators (IPGs)	Medtronic, Inc. Mounds View, MN 55112	Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components.
P970018/S014 11/7/08 Real-Time	PrepStain™ System	BD Diagnostics Durham , NC 27703	Approval for a design change to improve shielding of the horizontal interface board and accompanying labeling changes to clarify precautions and instructions.
P980006/S013 11/3/08 Real-Time	Bausch & Lomb® Purevision® (balafilcon A) Visibility Tinted Contact Lens	Bausch & Lomb, Inc. Rochester , NY 14609	Approval for using a new supplier of polypropylene resin for the contact lens blister packs.
P980016/S145 11/21/08 180-Day	Various Families of ICDs	Medtronic, Inc. Mounds View, MN 55112	Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components.
P980022/S034 11/24/08 180-Day	CareLink™ Pro (Model Number MMT-7335)	Medtronic MiniMed, Inc. Northridge , CA 91325	Approval for an update of software used in the CareLink™ pro, model MMT-7335 to version 1.2A.
P980023/S031 11/4/08 180-Day	Cardiac Airbag and Belos Families of ICDs	Biotronik, Inc. Lake Oswego , OR 97035	Approval for the addition of models 500/540 to the Lumax family of ICD/CRT-Ds and ICS 3000 Programmer. These models would contain: • A third programmable cardioversion / defibrillation shock pathway to offer more programming options • Automatic Threshold Measurement (ATM) feature • Electronic module (hardware) updates to support the third programmable shock path • Modifications to the Litronik batteries to increase capacity • New standard value of the programmable pacing pulse width • Updated RAM firmware to support new features
P980023/S035 11/21/08 Real-Time	Cardiac Airbag-T and Belos VR-T Implantable Cardioverter Defibrillators	Biotronik, Inc. Lake Oswego , OR 97035	Approval for updates to the Home Monitoring Service Center used with the Philos II and Cylos Families of Pulse Generators Lexos and Lumos Families of Implantable Cardioverter Defibrillators. Stratos LV-T Pulse Generator. Cardiac Airbag-T and Belos VR-T Implantable Cardioverter Defibrillators, and the Kronos LV-T and Lumax Families of Implantable Cardioverter Defibrillators.
P980035/S095 11/5/08 135-Day	Adapta/Sensia/ Versa Family of Implantable Pulse Generators (IPGs)	Medtronic, Inc. Mounds, View, MN 55112	Approval for a new weld system.
P980035/S097 11/26/08 180-Day	Medtronic Relia Implantable Pulse Generators	Medtronic, Inc. Mounds, View, MN 55112	Approval for the Medtronic Relia™ series of pulse generators which are rate responsive, multi-programmable, single and dual chamber devices (Models REDR01, RED01, REVDD01, RESR01, RES01) and the associated SW010 applications software (Version 1.0).
P980035/S102 11/19/08 135-Day	Adapta, Versa and Sensia Pacemakers	Medtronic, Inc. Mounds, View, MN 55112	Approval for a reduction in the hybrid burn-in stress time for the Adapta, Versa, and Sensia pacemakers.
P980035/S107 11/21/08 180-Day	Various Families of Implantable Pulse Generators (IPGs)	Medtronic, Inc. Mounds View, MN 55112	Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components.
P980035/S119 11/25/08 Real-Time	Adapta, Versa and Sensia Family of Pacemakers	Medtronic, Inc. Minneapolis , MN 55112	Approval for a minor design change for the L174 Hall sensor component used in the Medtronic Adapta, Versa and Sensia family of pacemakers.
P980049/S036 11/6/08 135-Day	ICDs Ovatio VR 6250 and DR 6550	ELA Medical, Inc. Plymouth , MN 55441	Approval for laser welding energy beam measurement intervals.
P980050/S035 11/21/08 180-Day	Various Families of ICDs	Medtronic, Inc. Mounds View, MN 55112	Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components.
P990001/S039 11/21/08 180-Day	Various Families of Implantable Pulse Generators (IPGs)	Medtronic, Inc. Mounds View, MN 55112	Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components.
P990012/S005 11/13/08 180-Day	Elecsys HBsAg Test System	Roche Diagnostics Indianapolis , IN 46250	Approval for the extension of the Elecsys HBsAg Test System and the Elecsys Anti-HBs Test System onto the updated model of the Elecsys 2010 analyzer, known as the cobas e 411 analyzer.
P990025/S016 11/7/08 Special	Navistar® RMT Catheter Family	Biosense Webster, Inc. Diamond Bar , CA 91765	Approval for two additional Quality Control inspection steps: 1) adding a 100% visual inspection of the PCB boards to verify that all components are present, and 2) adding an EEPROM read step during the existing calibration process to verify that all PCB components are present and functioning properly.
P990056/S007 11/18/08 180-Day	Elecsys® Total PSA Test System on cobas® e 411 Immunoassay Analyzer	Roche Diagnostics Indianapolis , IN 46250	Approval for extension of the Elecsys® total PSA and CalSet II onto the updated model of the Elecsys 2010 analyzer, cobas® e 411 analyzer.
P000008/S013 11/25/08 135-Day	LAP-BAND® Adjustable Gastric Banding (LAGB®) System	Allergan, Inc. Santa Barbara , CA 93111	Approval for the implementation of a skip-lot testing option for the Force to Close test.
P000009/S026 11/4/08 180-Day	Lumox, Xelos, and Lexos Families of ICDs	Biotronik, Inc. Lake Oswego , OR 97035	Approval for the addition of models 500/540 to the Lumax family of ICD/CRT-Ds and ICS 3000 Programmer. These models would contain: • A third programmable cardioversion / defibrillation shock pathway to offer more programming options • Automatic Threshold Measurement (ATM) feature • Electronic module (hardware) updates to support the third programmable shock path • Modifications to the Litronik batteries to increase capacity • New standard value of the programmable pacing pulse width • Updated RAM firmware to support new features
P000009/S031 11/21/08 Real-Time	Lexos and Lumos Families of Implantable Cardioverter Defibrillators	Biotronik, Inc. Lake Oswego , OR 97035	Approval for updates to the Home Monitoring Service Center used with the Philos II and Cylos Families of Pulse Generators Lexos and Lumos Families of Implantable Cardioverter Defibrillators. Stratos LV-T Pulse Generator. Cardiac Airbag-T and Belos VR-T Implantable Cardioverter Defibrillators, and the Kronos LV-T and Lumax Families of Implantable Cardioverter Defibrillators.
P000018/S043 11/19/08 180-Day	Beta Cath System	Best Vascular Norcross , GA 30093	Approval of the post-approval study protocol.
P000054/S018 11/24/08 135-Day	Infuse® Bone Graft	Medtronic, Inc. Memphis , TN 381132	Approval for additional treatment processing vessels, upgrades to process equipment and automation of a test method.
P000058/S029 11/24/08 135-Day	Infuse® Bone Graft/LT-Cage Lumbar Tapered Fusion Device	Medtronic, Inc. Memphis , TN 381132	Approval for additional treatment processing vessels, upgrades to process equipment and automation of a test method.
P010012/S189 11/17/08 180-Day	Cognis Family of CRT-D’s	Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112	Approval for the Next Generation (G2) RF communicator, Model 6476, which in conjunction with the Latitude System Software, v5.0, Model 6488, will add Latitude support for Cognis Teligen PGs.
P010014/S022 11/21/08 Special	Oxford® Meniscal Unicompartmental Knee System	Biomet, Inc. Warsaw , IN 46581	Approval for the addition of a check of thickness prior to engraving of the meniscal bearing components of the Biomet Oxford Meniscal Unicompartmental Knew System to prevent components from being mis-engraved.
P010015/S048 11/21/08 180-Day	InSync Family of Cardiac Resynchronization Therapy (CRT) Pacemakers	Medtronic, Inc. Mounds View, MN 55112	Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components.
P010030/S012 11/14/08 Real-Time	LifeVest Wearable Defibrillator	Zoll Lifecor Corporation Pittsburgh , PA 15238	Approval for two new Lithium ion cells that are used to construct the WCD 3000 battery pack.
P010031/S114 11/21/08 180-Day	Various Families of CRT-Defibrillators	Medtronic, Inc. Mounds View, MN 55112	Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components.
P010054/S007 11/13/08 180-Day	Elecsys Anti-HBs Test System	Roche Diagnostics Indianapolis , IN 46250	Approval for the extension of the Elecsys HBsAg Test System and the Elecsys Anti-HBs Test System onto the updated model of the Elecsys 2010 analyzer, known as the cobas e 411 analyzer.
P010068/S013 11/7/08 Special	Navistar® RMT Catheter Family	Biosense Webster, Inc. Diamond Bar , CA 91765	Approval for two additional Quality Control inspection steps: 1) adding a 100% visual inspection of the PCB boards to verify that all components are present, and 2) adding an EEPROM read step during the existing calibration process to verify that all PCB components are present and functioning properly.
P020004/S035 11/5/08 180-Day	Gore Excluder AAA Endoprosthesis	W.L. Gore & Associates, Inc. Flagstaff , AZ 86003	Approval for the distribution of the 2008 Annual Clinical Update to Physician Users for the Gore Excluder AAA Endoprosthesis.
P020014/S021 11/7/08 Real-Time	Conceptus Essure™ System for Permanent Birth Control	Conceptus, Inc. Mountain View , CA 94041	Approval for minor design changes to the Essure System, i.e., dimensional specification of the Delivery Wire Holder; change to the Release Band positioning; and a change to the Heat Shrink Tubing length.
P020018/S029 11/17/08 135-Day	Zenith Flex® AAA Endovascular Graft and Renu™ AAA Ancillary Graft	Cook Medical, Inc. Bloomington , IN 47402	Approval for an alternate vendor for polyester suture.
P020026/S052 11/14/08 135-Day	Cordis CYPHER® Sirolimus-Eluting Coronary Stent	Cordis Corporation Miami Lakes , FL 33014	Approval for reduction in a final acceptance activity test.
P020045/S025 11/14/08 Special	Freezor Cardiac CryoAblation Catheters – Freezor Xtra and Freezor MAX Surgical CryoAblation Catheters and CCT.2 CryoConsole System	Cryocath Technologies., Inc. Kirkland , Canada H9H 5H3	Approval for changing the manufacturing process of electrical cable subassembly.
P020056/S008 11/4/08 180-Day	Allergan, Inamed Silicone Filled Breast Implant (Large PAS)	Allergan Goleta , CA 93117	Approval of the post-approval study protocol.
P030009/S025 11/4/08 135-Day	Driver and Micro-Driver Coronary stent System	Medtronic Vascular Santa Rosa , CA 95403	Approval for the automation of the stent segment loading process.
P030017/S029 11/18/08 180-Day	Precision® Spinal Cord Stimulation (SCS) System	Boston Scientific Neuromodulation Sylmar , CA 91342	Approval for a manufacturing site located at Boston Scientific Neuromodulation, Valencia, California.
P030025/S051 11/18/08 180-Day	TAXUS™ Express 2™ Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Maple Grove , MN 55311	Approval for a manufacturing site located at Boston Scientific Corporation, Plymouth, Minnesota to manufacture the polymer excipient used in the device.
P030031/S012 11/7/08 Special	Navistar® RMT Catheter Family	Biosense Webster, Inc. Diamond Bar , CA 91765	Approval for two additional Quality Control inspection steps: 1) adding a 100% visual inspection of the PCB boards to verify that all components are present, and 2) adding an EEPROM read step during the existing calibration process to verify that all PCB components are present and functioning properly.
P030054/S098 11/26/08 135-Day	Epic HF/Atlas + HF Family of CRT-Ds	St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086	Approval for a change to eliminate a chemical cleaning process for titanium case halves.
P030054/S106 11/14/08 Real-Time	HV Ceramic RF Module for the Current RF ICDs and Promote RF CRT-Ds	St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086	Approval for the HV Ceramic RF Module for the Current RF ICDs and Promote RF CRT-Ds.
P030054/S107 11/14/08 Real-Time	Cadence ICD System Merlin@home Model EX1100 Transmitter	St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086	Approval for the Merlin@home Model EX1100 Transmitter with inductive telemetry.
P030054/S109 11/26/08 Real-Time	Promote CRT-D	St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086	Approval for minor changes to the Xena controller integrated circuit chip in the Current and Promote ICD/CRT-D devices.
P040002/S019 11/4/08 180-Day	Powerlink 34mm Infrarenal Proximal Cuff Accessory	Endologix, Inc. Irvine , CA 92618	Approval for the 34mm infrarenal proximal cuff accessory for the Powerlink system.
P040016/S005 11/18/08 180-Day	Liberté Monorail and Over-the-Wire Coronary Stent Systems	Boston Scientific Corporation Maple Grove , MN 55311	Approval for a manufacturing site located at Boston Scientific Ireland, Ltd. (BSIL), Galway, Ireland.
P040033/S006 11/13/08 180-Day	Birmingham Hip Resurfacing (BHR) System	Smith & Nephew Orthopaedics Alexandria , VA 22314	Approval for a line extension to the BHR System (ie., modular version of the BHR cup for uses with optional screws and apex/screw hold covers) and a site change (Smith & Nephew, Inc., Memphis, Tennessee).
P040036/S009 11/7/08 Special	Navistar® RMT Catheter Family	Biosense Webster, Inc. Diamond Bar , CA 91765	Approval for two additional Quality Control inspection steps: 1) adding a 100% visual inspection of the PCB boards to verify that all components are present, and 2) adding an EEPROM read step during the existing calibration process to verify that all PCB components are present and functioning properly.
P040038/S013 11/10/08 135-Day	Xact® Carotid Stent System	Abbott Vascular, Inc. Santa Clara , CA 95054	Approval to move the Xact® manufacturing processes within the existing manufacturing facility and to move two pieces of duplicate manufacturing equipment from one building to another.
P040043/S024 11/7/08 Real-Time	Gore TAG Thoracic Endoprosthesis Delivery System	W.L. Gore & Associates, Inc. Flagstaff , AZ 86003	Approval for modifications to the distal end of the delivery system where the endograft is constrained and changes to the delivery catheter hub, and is indicated for endovascular repair of aneurysms of the descending thoracic aorta in patients who have appropriate anatomy.
P050016/S004 11/4/08 180-Day	Cormet Hip Resurfacing System	Corin USA Tampa , FL 33612	Approval of the post-approval study protocol.
P050023/S011 11/4/08 180-Day	Lumax Family of ICD/CRT-Ds	Biotronik, Inc. Lake Oswego , OR 97035	Approval for the addition of models 500/540 to the Lumax family of ICD/CRT-Ds and ICS 3000 Programmer. These models would contain: • A third programmable cardioversion / defibrillation shock pathway to offer more programming options • Automatic Threshold Measurement (ATM) feature • Electronic module (hardware) updates to support the third programmable shock path • Modifications to the Litronik batteries to increase capacity • New standard value of the programmable pacing pulse width • Updated RAM firmware to support new features
P050023/S018 11/21/08 Real-Time	Kronos LV-T and Lumax Families of Implantable Cardioverter Defibrillators	Biotronik, Inc. Lake Oswego , OR 97035	Approval for updates to the Home Monitoring Service Center used with the Philos II and Cylos Families of Pulse Generators Lexos and Lumos Families of Implantable Cardioverter Defibrillators. Stratos LV-T Pulse Generator. Cardiac Airbag-T and Belos VR-T Implantable Cardioverter Defibrillators, and the Kronos LV-T and Lumax Families of Implantable Cardioverter Defibrillators.
P050028/S001 11/12/08 Real-Time	COBAS TaqMan HBV Test for use with the High Pure System	Roche Molecular Systems, Inc. Pleasanton , CA 94588	Approval for the shelf life extension of the TaqMan HBV Test components/kits in the COBAS TaqMan HBV Test for use with the High Pure System.
P050039/S001 11/13/08 180-Day	Novation™ Ceramic AHS™	Exactech, Inc. Gainsville , FL 32653	Approval for an additional machining processes at Exactech, Inc. in Gainesville, Florida.
P050039/S002 11/19/08 135-Day	Exactech® Novation® Ceramic AHS® Articulation Hip System	Exactech Gainesville , FL 32653	Approval for the addition of a new raw material supplier.
P050051/S003 11/13/08 Real-Time	Architect® AUSAB® Reagent Kit, Architect® AUSAB® Calibrators and Architect® AUSAB® Controls	Abbott Laboratories Abbott Park , IL 60064	Approval for change of grayzone range and changes to the output of the assay file interpretation screen.
P050053/S009 11/24/08 135-Day	Infuse® Bone Graft	Medtronic, Inc. Memphis , TN 381132	Approval for additional treatment processing vessels, upgrades to process equipment and automation of a test method.
P060033/S010 11/4/08 135-Day	Endeavor Zotarolimus-Eluting Coronary Stent System	Medtronic Vascular Santa Rosa , CA 95403	Approval for the automation of the stent segment loading process.
P060037/S004 11/6/08 180-Day	Legacy Knee-Posterior Stabilized (LPS), Flex Mobile Bearing Knee	Zimmer, Inc. Warsaw , IN 46581	Approval of the post-approval study protocol.
P070008/S001 11/4/08 180-Day	Stratos LV/LV-T Family of CRT-Ps	Biotronik, Inc. Lake Oswego , OR 97035	Approval for the addition of models 500/540 to the Lumax family of ICD/CRT-Ds and ICS 3000 Programmer. These models would contain: • A third programmable cardioversion / defibrillation shock pathway to offer more programming options • Automatic Threshold Measurement (ATM) feature • Electronic module (hardware) updates to support the third programmable shock path • Modifications to the Litronik batteries to increase capacity • New standard value of the programmable pacing pulse width • Updated RAM firmware to support new features
P070008/S005 11/6/08 180-Day	Stratos LV CRT-P & Stratos LV-CRT-P OTW Lead & COROX OTW BP Lead	Biotronik, Inc. Lake Oswego , OR 97035	Approval of the post-approval study protocol.
P070008/S007 11/21/08 Real-Time	Stratos LV-T Pulse Generator	Biotronik, Inc. Lake Oswego , OR 97035	Approval for updates to the Home Monitoring Service Center used with the Philos II and Cylos Families of Pulse Generators Lexos and Lumos Families of Implantable Cardioverter Defibrillators. Stratos LV-T Pulse Generator. Cardiac Airbag-T and Belos VR-T Implantable Cardioverter Defibrillators, and the Kronos LV-T and Lumax Families of Implantable Cardioverter Defibrillators.
P070016/S001 11/26/08 180-Day	Zenith® TX2® Thoracic Endovascular Graft	Cook, Inc. Bloomington , IN 47404	Approval of the post-approval study protocol.
P070016/S002 11/25/08 180-Day	Zenith® TX2® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System	Cook, Inc. Bloomington , IN 47404	Approval for use of a modified introduction system, the Z-Trak™ Plus Introduction System, with the Zenith TX2® TAA Endovascular Graft.
P070027/S002 11/5/08 180-Day	Talent Abdominal Stent Graft System	Medtronic, Inc. Santa Rosa , CA 95403	Approval of the post-approval study protocol.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P780007/S044 11/21/08	Biomedics 38 (Polymacon) Hydrophilic Contact Lenses	CooperVision, Inc. Norfolk , VA 23507	Migration to an in-blister hydration process for the Polymacon 38 lenses.
P840001/S121 11/6/08	RestoreULTRA Implantable Neurostimulator	Medtronic Neuromodulation Minneapolis , MN 55432	Addition of a dual pin press to the manufacturing process.
P840064/S037 11/26/08	VISCOAT®, DUOVISC®, DISCOVISC®, PROVISC® AND CELLUGEL® Ophthalmic Viscosurgical Devices	Alcon Research, Ltd. Fort Worth , TX 76134	Use of a new industrial disinfectant for the disinfection of cleanrooms used during the production process.
P860019/S229 11/4/08	PTCA Catheters	Boston Scientific Corporation Maple Grove , MN 55311	Alternate method for final packaging of the device including label design changes under the BSC master brand.
P880086/S169 11/13/08	Affinity, Integrity, Identity, Victory, and Zephyr Family of Pacemakers	St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086	Addition of an alternate vendor for the parylene dimer used to parylene coat pacemakers and CRT-Ps
P890003/S152 11/14/08	Model 2490C and 2490R CareLink® Monitors	Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112	Changes to the test codes applied during the inline quality control test system used for the device.
P890047/S025 11/26/08	VISCOAT®, DUOVISC®, DISCOVISC®, PROVISC® AND CELLUGEL® Ophthalmic Viscosurgical Devices	Alcon Research, Ltd. Fort Worth , TX 76134	Use of a new industrial disinfectant for the disinfection of cleanrooms used during the production process.
P910023/S192 11/21/08	Cadence Family of ICDs	St. Jude Medical, Inc. Sylmar , CA 91342	Addition of an alternate vendor to package ICD plugs.
P920015/S049 11/26/08	Sprint Quattro Secure Lead Models 6935 and 6947	Medtronic, Inc. Mounds View, MN 55112	Modification to the sleeve head bonding process and to the Adhesive Dab Application to the Overlay Tubing Slit process.
P940040/S010 11/25/08	Roche Molecular Systems AMPLICOR Mycobacterium Tuberculosis (MTB) Test	Roche Molecular Systems, Inc. Pleasanton , CA 94588	Replacement of Tetrazole, an activator used in the automated DNA synthesis of RMS oligonucleotides use in the AMPLICOR Mycobacterium Tuberculosis (MTB) Test with the activator 4,5 Dicyanoimidazole (DCI).
P960030/S024 11/26/08	IsoFlex Optim Family of Leads	St. Jude Medical CRMD Sylmar , CA 91342	Elimination of the plasma priming process.
P960040/S179 11/21/08	Vitality AVT, Confient, Confient AV, Vitality DS, Vitality EL, Vitality DS VR, Vitality 2 DR, Vitality 2 DR EL, Vitality 2 VR, Vitality 2 VR EL, Vitality HE	Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112	Changes in the soak process time for high voltage capacitors and the addition of digital timers to the primary soak ovens.
P970004/S063 11/25/08	InterStim II® Model 3058 Neurostimulator	Medtronic, Inc. Minneapolis , MN 55432	Change in the final clean and inspection process for the device.
P970008/S040 11/19/08	Urologix Targix® System	Urologix, Inc. Minneapolis , MN 55447	Change of an adhesive and the test method for measuring tensile strength.
P980016/S160 11/5/08	Maximo, Marquis, Intrinsic 30/ Intrinsic, EnTrust, and Virtuoso ICDs	Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112	Addition of an in-process leakage test.
P980016/S161 11/7/08	Maximo DR/VR, Marquis DR/VR, and Intrinsic ICDs	Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112	Addition of a cleaning step.
P980016/S162 11/13/08	Virtuoso ICD	Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112	Alternate vendor of raw material used in flex circuit manufacture.
P980022/S038 11/14/08	Medtronic MiniMed Continuous Glucose Monitoring System	Medtronic Diabetes Northridge , CA 91325	Changes to the rinse and dry times, addition of a new adhesive for the occlusion sensor, and change to the sensor encasement.
P980022/S039 11/20/08	Medtronic MiniMed Continuous Glucose Monitoring System	Medtronic Diabetes Northridge , CA 91325	Changes to the sensor to tube assembly, sealing and beveling.
P980022/S040 11/24/08	Paradigm Real-Time Insulin Pump	Medtronic MiniMed Northridge , CA 91325	Change in a vendor supplying a component of the device.
P990023/S005 11/26/08	VISCOAT®, DUOVISC®, DISCOVISC®, PROVISC® AND CELLUGEL® Ophthalmic Viscosurgical Devices	Alcon Research, Ltd. Fort Worth , TX 76134	Use of a new industrial disinfectant for the disinfection of cleanrooms used during the production process.
P010012/S193 11/21/08	Vitality AVT, Confient, Confient AV, Vitality DS, Vitality EL, Vitality DS VR, Vitality 2 DR, Vitality 2 DR EL, Vitality 2 VR, Vitality 2 VR EL, Vitality HE	Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112	Changes in the soak process time for high voltage capacitors and the addition of digital timers to the primary soak ovens.
P010031/S128 11/5/08	Concerto, InSync Sentry, InSync Sentry, InSync II Marquis, InSync III Marquis, InSync II Protect, and InSync Maximo CRT-Ds	Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112	Addition of an in-process leakage test.
P010031/S129 11/13/08	Concerto CRT-D	Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112	Alternate vendor of raw material used in flex circuit manufacture.
P020004/S038 11/26/08	Gore Excluder® AAA Endoprosthesis (Excluder Device)	W.L. Gore & Associates, Inc. Flagstaff , AZ 86001	Change in the method used for cooling the endoprosthesis prior to crushing and subsequent loading onto the delivery device.
P020009/S047 11/4/08	Express 2 MR & OTW Coronary Stent System	Boston Scientific Corporation Maple Grove , MN 55311	Alternate method for final packaging of the device including label design changes under the BSC master brand.
P030009/S027 11/13/08	Driver Coronary Stent Systems	Medtronic Vascular, Inc. Santa Rosa , CA 95403	Modification of the manufacturing equipment to allow increased capacity.
P030035/S048 11/13/08	Frontier and Frontier II Family of CRT-Ps	St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086	Addition of an alternate vendor for the parylene dimer used to parylene coat pacemakers and CRT-Ps
P040047/S009 11/14/08	Coaptite® Injectable Implant	BioForm Medical, Inc. Franksville , WI 53126	Addition of a new supplier for a component used in the packaging of the device.
P050028/S002 11/25/08	Roche Molecular Systems COBAS TaqMan HBV Test for use with the High Pure System	Roche Molecular Systems, Inc. Pleasanton , CA 94588	Replacement of Tetrazole, an activator used in the automated DNA synthesis of RMS oligonucleotides use in the COBAS TaqMan HBV Test for use with the High Pure System with the activator 4,5 Dicyanoimidazole (DCI).
P050037/S012 11/6/08	Radiesse Injectable Gel	BioForm Medical, Inc. Franksville , WI 53126	Qualification of a modified pyrogen test method.
P050037/S013 11/14/08	Radiesse® Injectable Implant	BioForm Medical, Inc. Franksville , WI 53126	New supplier for a packaging component for the device.
P050037/S014 11/21/08	Radiesse ® Injectable Gel	BioForm Medical, Inc. Franksville , WI 53126	Alternate vendor for glycerin, a component used in the device.
P050044/S006 11/14/08	Vitagel™ Surgical Hemostat	Orthovita, Inc. Malvern , PA 19355	Installation of a second manufacturing line.
P050044/S007 11/21/08	Vitagel™ Surgical Hemostat	Orthovita, Inc. Malvern , PA 19355	Change of vendor and change of manufacturing parameters.
P050052/S013 11/6/08	Radiesse Injectable Gel	BioForm Medical, Inc. Franksville , WI 53126	Qualification of a modified pyrogen test method.
P050052/S014 11/14/08	Radiesse® Injectable Implant	BioForm Medical, Inc. Franksville , WI 53126	New supplier for a packaging component for the device.
P050052/S015 11/21/08	Radiesse ® Injectable Gel	BioForm Medical, Inc. Franksville , WI 53126	Alternate vendor for glycerin, a component used in the device.
P060008/S001 11/21/08	TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System (Over-the-Wire)	Boston Scientific Corporation Maple Grove , MN 55311	Change in supplier of a device component.
P060008/S002 11/20/08	TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Maple Grove , MN 55311	Change to an in-process test method and corresponding specifications.
P060008/S003 11/20/08	TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Maple Grove , MN 55311	Implementation of an in-process automated manufacturing improvement.
P060008/S005 11/26/08	TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Maple Grove , MN 55311	Change in the method used to create the proximal marks on the shaft of the Over-the-Wire catheter.
P060008/S006 11/26/08	TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Maple Grove , MN 55311	Implementation of an in-process automated manufacturing improvement.
P060022/S001 11/19/08	Akreos® Posterior Chamber Intraocular Lens	Bausch & Lomb, Inc., Rochester , NY 14609	Change in site for the bioburden and endotoxin testing.
P060025/S001 11/26/08	ATS 3f® Aortic Bioprosthesis	ATS Medical, Inc. Lake Forest , CA 92630	Change in supplier for the Tab Cloth fabric.
P060033/S015 11/13/08	Endeavor Sprint Zotarolimus-Eluting Coronary Stent System	Medtronic Vascular Santa Rosa , CA 95403	Change in vendor for molded components used in the manufacture of the device.
P060033/S016 11/13/08	Endeavor Sprint Zotarolimus-Eluting Coronary Stent System	Medtronic Vascular Santa Rosa , CA 95403	Equipment modification to increase the capacity at an in-process work step.
P060033/S017 11/19/08	Endeavor Sprint Zotarolimus-Eluting Coronary Stent System	Medtronic Vascular Santa Rosa , CA 95403	Changes to the Endeavor Sprint Zotarolimus-Eluting Coronary Stent System: 1) reuse of catheter hoops; 2) eliminate pre-PC spray inspection work step; 3) welding process automation; 4) alternative pouch sealing equipment; 5) change to stent storage and transportation vial; and 6) conical spray jar assembly.
P060033/S018 11/20/08	Endeavor Zotarolimus-Eluting and Endeavor Sprint Zotarolimus-Eluting Coronary Stent System	Medtronic Vascular Santa Rosa , CA 95403	Change to the packaging and loading configurations used in the sterilization process.
P060033/S019 11/13/08	Driver Coronary Stent Systems	Medtronic Vascular, Inc. Santa Rosa , CA 95403	Modification of the manufacturing equipment to allow increased capacity.
P060033/S024 11/26/08	Endeavor Zotarolimus-Eluting Coronary Stent System and Endeavor Sprint Zotarolimus-Eluting Coronary Stent System	Medtronic Vascular, Inc. Santa Rosa , CA 95403	Changes to the in-process monitoring at the PC Overspray workstep.

Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 98

Summary of PMA Originals Under Review
Total Under Review: 67
Total Active: 27
Total On Hold: 40
Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review
Total Under Review: 535
Total Active: 348
Total On Hold: 187
Number Greater Than 180 Days: 18

Summary of All PMA Submissions Received
Originals: 1
Supplements: 183

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 98
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 177
FDA Time: 95.4 Days MFR Time: 81.6 Days

Updated December 16, 2008

horizonal rule

Center for Devices and Radiological Health / CDRH